Description of use

Intended Use: Detects foci of prostate carcinoma that are likely positive for mutations on digital images from prostate biopsies & resections. If morphological phenotypes consistent with the following mutations are detected, it will classify the sample as positive. Androgen Receptor (AR) amplification: AR Compound tumor suppressor genes alterations, includes alterations in Tumour protein p53 (TP53), Phosphatase and tensin homolog (PTEN), Retinoblastoma protein 1 (RB1). It is the responsibility of a qualified pathologist to employ appropriate procedures to ensure the quality of the images obtained. This result infers a likelihood of positivity and /or negativity and may require further molecular testing to determine the ground truth of the alteration present.